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U.S. Department of Health and Human Services

Class 3 Device Recall Cardinal Health Hydroxybutyrate LiquiColor

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  Class 3 Device Recall Cardinal Health Hydroxybutyrate LiquiColor see related information
Date Initiated by Firm July 12, 2021
Create Date August 05, 2021
Recall Status1 Terminated 3 on March 29, 2022
Recall Number Z-2202-2021
Recall Event ID 88323
510(K)Number K910108  
Product Classification Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
Product Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Code Information Catalog Number/Product Description: CH2440058/Cardinal Health ¿-Hydroxybutyrate LiquiColor Device Identifier: 10885380173127 Lot Numbers: 166355; 165053; 163944; 162092;
Recalling Firm/
Manufacturer		 Stanbio Laboratory, LP
1261 N Main St
Boerne TX 78006-3014
For Additional Information Contact
800-531-5535
Manufacturer Reason
for Recall		 Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 07/12/2021, the firm sent an "PRODUCT CORRECTION NOTIFICATION" Letter via First Class mail (U.S.) and email (O.U.S.) to inform customers that the Recalling Firm has observed deterioration in the stability of the liquid reagents which has resulted in lower than expected or out of range Quality Control values. Customers are instructed to: 1) Discontinue use of and quarantine any affected product. 2) Only the lot listed in the table provided are affected and customers may continue to use any other lots they may have in their possession. 3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 4) If customers have forwarded the product to another laboratory, please provide a copy of this letter to them. Provide the name, address and a contact for the laboratory on the Verification Form. 5) Complete and FAX or email the enclosed Verification Form within 10 days to confirm their receipt of this notice. If you have further questions, please contact Technical Support at 1-800-531-5535 ext. 128.
Quantity in Commerce 3,940 units
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JIN and Original Applicant = GDS DIAGNOSTICS
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